Sanofi recalls TB vaccine over quality issues

Share this Article

TORONTO – The sole supplier of tuberculosis vaccine in Canada has recalled all doses because of concerns the product may have been contaminated.

Health Canada announced Friday that Sanofi Pasteur was recalling roughly 4,700 vials — or 47,000 doses — of the so-called BCG vaccine. Another 1,000 vials produced as part of the affected lots had not been distributed by the company.

The concerns came to light following routine inspections of the company’s Toronto manufacturing facility in May and early June, a senior Health Canada official said in an interview.

Dr. Paul Gully said the building in which the vaccine is made was flooded last October, and there remain ongoing production challenges related to the flood.

“It made Health Canada concerned there is a possibility of contamination,” said Gully, senior medical adviser to the deputy minister of Health Canada. Gully said, though, that testing so far has not identified any contaminated product.

Three adverse reactions potentially linked to the recalled vaccine lots have been reported. All were the kind of mild reactions normally associated with this vaccine, Health Canada said.

There was no one at Sanofi’s Canadian operations who could comment on the recall on Friday.

While Sanofi Pasteur makes other vaccines at its Toronto plant, only BCG vaccine is made in the affected building. BCG stands for Bacille Calmette-Guerin, named after Albert Calmette and Camille Guerin who developed the live-bacteria vaccine in the early 1900s.

BCG is also used as a treatment for bladder cancer. The bladder cancer product is made in the same building as the vaccine, but those lots are not being recalled. Gully explained the risk-benefit ratio is different when one is trying to prevent serious disease (in the case of the vaccine) versus when one is trying to treat it (the bladder cancer).

Health Canada has reached out to five other manufacturers that make BCG vaccines. None of them has a license to market TB vaccine in Canada, but there are means by which vaccine approvals can be expedited under circumstances like this. Some of the products have been pre-approved by the World Health Organization, Gully said.

How long the country will be without tuberculosis vaccine is unclear at this point. “I can’t give you a time frame because it does take time to do this,” Gully said.

The vaccine is not widely used in Canada. It is mainly employed to protect young children living in First Nations and Inuit communities where the risk of TB outbreaks is high.

BCG is not considered a very good vaccine, said Dr. Michael Gardam, director of the tuberculosis clinic at Toronto’s University Health Network. It does not prevent infection. But young children who receive it have a lower risk of developing severe disease — tuberculosis meningitis or disseminated TB — if they become infected.

Gardam said the recall is an inconvenience, but is unlikely to trigger a public health crisis.

Even the jurisdiction with Canada’s worst TB problem — Nunavut — seemed to be taking the recall in stride.

Dr. Maureen Baikie, deputy chief medical officer for Nunavut, said the territory had returned all BCG vaccine and suspended its vaccination program as of Friday. It is also informing the parents of children who received vaccine from the recalled lots, she said.

Figures compiled by the Public Health Agency of Canada show that in 2009, Nunavut had 174 TB cases per 100,000 people. No other province or territory came close to that rate. The Northwest Territories, which had the second highest rate, recorded 27.6 cases per 100,000 people that year.

Baikie said the territory’s tuberculosis prevention program has a number of components, of which the vaccine is just one. Those other components include actively looking for cases, finding the contacts of cases and treating cases with what is called directly observed therapy. That means watching people take their antibiotics, an approach which has been shown to increase the number of people who complete their full course of treatment.

Baikie said there has only been one case of TB meningitis and one possible case of disseminated TB in the territory in the past five years. Both were recorded in 2008, in three year olds. The children were successfully treated with antibiotics, she said.